Interest in Studying Fibroblast Before and After Neoadjuvant Chemo-radiotherapy in Patient With Locally Advanced Rectal Adenocarcinoma : Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 6
- 主要终点
- Proteomic level evaluation in intra-tumor fibroblast
研究概览
简要总结
Single center interventional study to explore activity of fibroblasts in the tumor and away in the healthy rectal tissue.
详细描述
Patients included in the trial will have new biopsy performed before starting the Radiation Therapy and Chemotherapy (RT-CT). These biopsies will study the activity of fibroblasts in the tumor and away in the healthy rectal tissue. Within 8 to 10 weeks after the end of RT-CT, patients will have cancer surgery by proctectomy (with complete removal of the meso-rectum). On the resection specimen, new samples will be taken at the level of the tumor and away from the rectum.This study is single center interventional exploratory .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Middle rectum adenocarcinoma Tumor(T)x Node (N)+ or T3 /T4 N0 or N+
- •Classification done on pelvic Magnetic Resonance Imaging (MRI) and rectal ultrasonography
- •No contraindication to treatment with capecitabine
- •Able to receive radiotherapy 50 Grays in 5 weeks
- •No contraindication for surgery after chemoradiotherapy which will be 8 to 10 weeks after completion of chemoradiotherapy
- •Patient or legal representative provided with information and signature of informed consent
排除标准
- •High rectum adenocarcinoma
- •Contraindication to rectal biopsy: including anti-coagulants or anti-platelet agents (vitamin K antagonists, clopidogrel, aspirin > 160 grams) that cannot be interrupted
- •Pregnant woman or breastfeeding
- •Persons deprived of their liberty, or under guardianship
- •Impossibility of undergoing the trial's medical follow-up for geographical, social or psychological reasons.
- •Patient already included in another therapeutic trial with an experimental medication during the realization of protocol biopsies and surgery
- •Patient not covered by health insurance
结局指标
主要结局
Proteomic level evaluation in intra-tumor fibroblast
时间窗: 3 years
Proteomic level is assessed before and after radiochemotherapy using SILAC technic (Stable Isotope Labeling by Amino acids in Cell culture)
次要结局
- Study of fibroblast impact on colorectal tumor cells (in vitro)(3 years)